This invention relates in general to programmable infusion pumps that are used to deliver controlled infusions (e.g., intravenous infusions, epidural infusions, subcutaneous infusion, etc.) to patients in hospitals or out-of-hospital settings. Programmable infusion pumps are used to administer a wide range of drugs, analgesic medications, sedation drugs, biological therapies and other substances, including but not limited to cancer chemotherapy, Immune Globulin therapy, insulin, etc. Programmable infusion pumps typically include safety features that control or limit the rate of infusion and the amount of solution delivered to the patient, thereby preventing inadvertent overdosing, underdosing and/or infusion rate related side effects. Some programmable infusion pumps also include other safety features such as air-in-line detectors, occlusion detectors, etc.
The infusion systems of the prior art have included varying degrees of programmability and/or safety features. One particular use of programmable infusion pump technology is in administration of medications in a hospital setting. In a typical use case of programmable infusion pumps in hospital setting, the pump is programmed to deliver a medication to the patient at a specific rate of infusion. There are various safety features that are implemented in the design and operation of the infusion pump to mitigate against system fault that may result in overdosing, underdosing, air infusion and other faults including but limited to electronic memory fault, mechanical fault, etc.
Under normal operating conditions the programmable infusion pump will infuse the medication at the commanded rate of infusion, and the safety systems are engaged to detect various potential system faults. If a fault such as air-in-line, the infusion pump will stop and sound an alarm to notify the attending clinician such as the nurse about the fault. The nurse will respond to the pump to silence the alarm and correct the fault by manually removing the air from the infusion line following a standard procedure. In some cases the nurse response is delayed and the patient will experience a longer interruption of the infusion. In some other fault cases the infusion pump may have a fault that requires service, and the nurse will replace the infusion pump. Under these conditions, and with some medications such as antibiotics, the interruption of infusion may be tolerated by the patient. Fail safe mode of stopping an infusion and sounding an alarm when a fault is detected has been the general approach in programmable infusion pumps.
Generally, the infusion pump is not considered a life supporting device under the regulatory guidelines. However, in recent pharmaceutical developments new potent drugs have emerged that are considered in some cases as life supporting drugs.
There remains a need in the art for the development of new programmable infusion system that can reliably infuse life supporting drugs and can tolerate common faults detected of the prior art and will safely continue the delivery of medication to the patient without the interruption experienced in the prior art.